Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012. The Breakthrough Designation is granted to the drugs as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available therapies […]Read More
Shots: The approval is based on P-III ECHELON-1 study result assessing Adcetris + AVD (adriamycin, vinblastine and dacarbazine) vs ABVD (adriamycin, bleomycin, vinblastine and dacarbazine) in patients with previously untreated CD30-positive and has met its 1EPs with 23% reduction in risk progression & improvement in PFS According to 2009 deal b/w Seattle Genetics & Takeda […]Read More
Shots: The FDA’s BT designation is based on P-III ECHELON-2 study results assessing Adcetris + CHP vs CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in 450 patients with CD30+ T-cell lymphoma across North America, EU and Asia The P-III ECHELON-2 study results: met it’s 1EPs & 2EPs; improvement in PFS, superior OS; CRR and ORR were statistically […]Read More
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